Packaging Quality Systems: Preventing the Audit Leak

Whether for a fresh startup or a seasoned medical device manufacturer (MDM), it is an outright necessity to ensure that packaging quality systems provide for a stringent operating environment that effectively mitigates the three tiers of risks: patient, compliance, and business. And for challenging such stringency, audits exist. Some may view audits, internal and external, as strenuous events, while others may opine about them as robustness tests.

Abhishek Gautam

Nevertheless, audits may lead to warnings/citations, which can transpire because of numerous reasons, namely upper-level-department strategy, lower-level execution, misalignment with ISO standards, misinterpretation of ISO standards, internal procedural compliance, documentation error, missing procedures, missing or incomplete validations, and many more to count.

The following list, while obviously not an all-inclusive one, comprises commonly reviewed and cited areas of scrutiny within the packaging engineering domain. All of such guidance can be related to ISO 13485, Part 820 of CFR Title 21, and ISO 11607: 1&2.

Packaging engineering training plans and training compliance

Packaging quality system procedures to govern (not all inclusive list)

My intent was to provide with a simplified list of requirements in guidance from some of major standards use by medical device industry. Obviously, the setting up and operations of business-specific packaging quality system is subjective to industry sector and classification of medical devices.